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Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome

Follow up Protocol to the Open Label Phase I/II Study OPN-305-106: A Prospective, Open Label Phase I/II Study to Assess the Safety and Efficacy of Cycles of Intravenously Infused Doses of OPN-305 in Second-line and Third-line Lower (Low and Intermediate-1) Risk Myelodysplastic Syndrome (MDS)

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03337451
Enrollment
14
Registered
2017-11-09
Start date
2018-02-27
Completion date
2019-01-10
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome

Brief summary

This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy treatment or combination treatment with azacitidine after completion of the dose confirming, dose expansion and HMA naïve parts of the main study OPN-305-106.

Interventions

DRUGOPN-305

Patients will receive study drug every 4 weeks

Sponsors

M.D. Anderson Cancer Center
CollaboratorOTHER
Montefiore Medical Center
CollaboratorOTHER
H. Lee Moffitt Cancer Center and Research Institute
CollaboratorOTHER
New York Presbyterian Hospital
CollaboratorOTHER
Opsona Therapeutics Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Completion of the OPN-305-106 study * Principal Investigator adjudicated efficacy response defined as either transfusion independence, stable disease, minor HI-E response or major HI-E response and in the opinion of the Principal Investigator the patient may benefit from continued treatment with OPN-305 monotherapy or combination treatment with azacitidine. * Provide written informed consent for the follow up protocol.

Exclusion criteria

* Refusal to provide written informed consent * Withdrawal from the OPN-305-106 study prior to the final EOT visit * Plan to be included into another interventional investigational study. * Progression of disease

Design outcomes

Primary

MeasureTime frameDescription
Incidence and types of Serious Adverse eventsmonthly through study completion, an average of 18 months—
monitor ongoing efficacy responsesmonthly through study completion, an average of 18 monthsTo monitor ongoing efficacy responses defined as transfusion independence. Transfusion independence is defined as 56 consecutive days where no RBC transfusions are given

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026